Pharma Quality & Complaints Compliance Specialist

Hims & Hers; United States; Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Unlimited PTO

Health benefits

ESPP

401k match

Team retreats

Job summary

Hims Hers is seeking a detail-oriented Quality Compliance Specialist to manage intake, investigation, and resolution of complaints related to prescription products. You will work across quality, compliance, and customer experience with pharmacy partners and medical teams to ensure thorough investigations and timely closures.

This role requires hands-on organization, knowledge of regulatory requirements (FDA 503A/503B), and a strong background in pharmaceutical complaint management.

Qualifications

• Active Pharmacy Technician or Pharmacist license preferred.
• Bachelor's degree preferred in a relevant science, quality, or engineering field; or an associate degree with equivalent experience will be considered.
• 4+ years of experience in pharmacy operations, quality assurance, or complaint handling in a regulated environment.
• Familiarity with 503A/503B compounding pharmacy regulations and FDA reporting requirements 21 CFR Parts 210/211, cGMP, and GDP practices.
• Understanding USP 795 and 800 standards and non-sterile compounding processes.

Responsibilities

• Investigate and resolve customer and partner complaints related to prescription products.
• Review complaint details and link orders and attribution with accuracy.
• Triage complaints to appropriate third parties based on description and location.
• Evaluate third-party investigations for adequate root cause analysis and request re-investigation if needed.
• Determine regulatory reportability and escalate when necessary.
• Monitor deadlines and escalate at-risk cases to leadership.
• Analyze trends and identify corrective actions from complaint data.
• Create regular metrics reports for senior leadership.

Skills

Pharmacist license

4+ years experience

Pharmacy operations

Complaint handling

FDA reporting

Quality standards

Analytical skills

Education

Bachelor's degree in science

Associate degree

Tools

Zendesk

Job description

Hims Hers is seeking a detail-oriented Quality Compliance Specialist to manage intake, investigation, and resolution of complaints related to prescription products. You will work across quality, compliance, and customer experience with pharmacy partners and medical teams to ensure thorough investigations and timely closures.

This role requires hands-on organization, knowledge of regulatory requirements (FDA 503A/503B), and a strong background in pharmaceutical complaint management.